Phase I Dose Escalation Study of ON 01910.Na with Increasing Duration of an Initial 3-Day Continuous Infusion in Patients with Refractory Leukemia or Myelodysplastic Syndrome (MDS)
ID Number 02-0587Principal Investigator(s)
Lewis R. Silverman
Department(s) or Division(s)
Hematology and Medical Oncology
The purpose of this study is to determine the safety of the study drug ON 01910.Na, which is an investigational drug that has not been approved by the United States Food and Drug Administration (FDA). The study will try to determine: (a) the highest tolerated dose (how much medication we can safely give to patients) (b) the severity of the side effects and (c) the recommended safe dose. At the same time, drug levels in the blood will be measured to obtain information about how much drug is accumulated in the bloodstream, how slowly or quickly the drug disappears from the blood stream, and how the drug is metabolized (a process of drug breakdown).
You may qualify to participate in this research study because (1) you have a diagnosis of a leukemia; acute myelocytic leukemia (AML); acute lymphocytic leukemia (ALL); chronic myelocytic leukemia (CML); chronic lymphocytic leukemia (CLL); or myelodysplastic syndrome (MDS), and (2) you have a disease which cannot be cured with known treatments and for which no other therapy is known to be consistently effective.
Recruiting Patients: Yes